The Drug Rediscovery Protocol (DRUP Trial)

This is a prospective, non-randomized clinical trial that aims to describe the efficacy and toxicity of commercially available, targeted anticancer drugs\* prescribed for treatment of patients with advanced cancer with a potentially actionable variant as revealed by a genomic or protein expression test. The study also aims to simplify patient access to approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies and to perform next generation sequencing on tumor biopsies for biomarker analyses. Eligible patients have an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma for which standard treatment options are no longer available and acceptable performance status and organ function. A genomic or protein expression test must have been performed on the tumor and the results must identify at least one potentially actionable molecular variant as defined in the protocol. Results from the molecular profiling test will be used to determine an appropriate drug(s) from among those available in the protocol. The choice of drug will be supported by a list of potential profiles, a molecular tumor board, a knowledge library and by study coordinators for review and approval of the match. The protocol-specified treatment will be administered to the patient once any drug-specific eligibility criteria are confirmed and a fresh pre-treatment biopsy is performed for future genetic studies. All patients who receive treatment with a drug available in the protocol will be followed for standard efficacy outcomes including tumor response, progression-free and overall survival as well as duration of treatment. In addition, treatment related toxicity will be evaluated.

NCT Number	NCT02925234
Lead Sponsor	The Netherlands Cancer Institute Collaborators: Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Novartis, Roche Pharma AG, Merck Sharp & Dohme LLC, Boehringer Ingelheim, Ipsen, Eisai Inc., Pfizer, Clovis Oncology - Pharma and, Eli Lilly and Company, Janssen, LP, GlaxoSmithKline, Incyte Corporation, Dutch Cancer Society, Stelvio for Life
Conditions	Cancer, Tumors, Neoplasm, Neoplasia
Enrollment	1,550 participants
Start Date	2016-08
Primary Completion	2027-09 (estimated)
Study Completion	2027-12 (estimated)
Updated on ClinicalTrials.gov	2024-01-24